FDA Inspection
American Association of Acupuncture and Bio-Energetic MediciAmerican Association of Acupuncture and Bio-Energetic Medici – FDA Inspection, Nov 5, 2010
Record Details
This FDA Inspection record concerns American Association of Acupuncture and Bio-Energetic Medici, with an inspection on November 5, 2010, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- November 5, 2010
- Product Type
- Devices
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ID · c63bf596-2348-43dd-9622-d523615cd55d
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 696529
- FDA center
- Medical Devices & Rad Health
- Project area
- Bioresearch Monitoring
FDA Citations
7- 21 CFR 56.115(a)(1)Copies of all research proposals and related documents
- 21 CFR 56.111(a)(1)Risks minimized by sound research design
- 21 CFR 56.108(a)(1)Initial and continuing reviews
- 21 CFR 56.109(e)IRB approvals/disapprovals - general
- 21 CFR 56.108(b)(3)Reporting of suspension/termination
- 21 CFR 56.108(b)(2)Prompt reporting of noncompliance
- 21 CFR 56.113Reporting
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Other FDA inspections of American Association of Acupuncture and Bio-Energetic Medici
1| Date | Classification | Office | Project area |
|---|---|---|---|
| February 8, 2013 | OAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
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